Director, Supplier Quality Engineering
In this role you will own the implementation of Quality Engineering, Purchasing Controls and Supplier Quality processes related to the development, procurement and continuous improvement of manufacturing materials, components, software, sub-assemblies, contract manufactured finished devices/products or services, and their introduction into Philips supply chain.
- You will partner with R&D, Operations and Procurement personnel to actively engineer quality and ensure compliance for raw materials, components, finished products etc., from suppliers.
- Developing and supporting regulatory compliance gaps at suppliers, including supplier quality system and process development activities.
- You will lead additions/deletions/changes to the status of suppliers on the Approved Supplier List, including supplier master file records.
- Ensuring raw materials/components/products at supplier(s) are released from supplier(s) to Philips according to the agreed requirements.
- Performing 3rd party product compatibility risk assessments in partnership with R&D and Market Procurement (Markets SQE).
- You will drive quality and compliance development and/or improvement at suppliers when needed; Philips face to supplier(s) on lean improvements.
- Driving shared accountability across stake holders to design, manufacture and distribute products right the first time from our supplier base.
- You will guide, manage and implement transparency within the organization and work closely with MT leadership/stake holders to drive key metrics to pro-actively improve supplier quality performance and reduce business revenue impact due to FCO’s, supplier QN notices, un-intended disruptions, and resolve supplier issues to business and regulatory compliance satisfaction.
To succeed in this role, you should have the following skills and experience
- Bachelor’s degree in an engineering or science discipline, or equivalent experience.
- Current certification with a recognized Accreditation body (i.e., RAB-QSA/IRCA) or successful completion of ASQ certification as a Certified Quality Engineer (CQE) and Certified Quality Auditor (CQA) or Certified Biomedical Auditor or successful completion of a recognized Lead Auditor course.
- 14+ years of total industry experience
- 10+ years of related experience in a medical device or regulated industry.
- Working knowledge of appropriate global medical device regulations, requirements and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, and ISO 9001.
- Expert level knowledge of methodologies, tools and techniques in Purchasing, Operations and SQE including due diligence processes.
- 7+ years of management experience.
- Preferred to have broader experience including procurement, manufacturing engineering and project engineering.